Under the Generic Drug User Fee Amendments of 2012 (GDUFA), if your facility, site, or organization is involved in human generic drug activities, you must submit annual self-identification information electronically to the FDA.
GDUFA self-identification is critical for staying compliant and supporting the FDA’s oversight of the generic drug industry. It helps the FDA determine who needs to pay user fees and improves transparency, enabling faster, more accurate surveillance and inspections. Most facilities that self-identify also need to pay an annual user fee.
Frequently Asked Questions
- Who needs to self-identify?
You must self-identify if you:
- Manufacture (or plan to manufacture) generic APIs or finished dosage forms (FDFs)
- Package FDFs into primary containers and label them
- Have a site named in a submission that transfers drugs from one container to another under contract
- Conduct BE/BA clinical testing, perform bioanalytical testing on BE/BA samples, or run in vitro BE testing
- Are listed in a submission to perform CGMP-required testing (excluding research-only testing)
- When do you need to submit?
You must submit your self-identification data to the FDA between May 1 and June 1 each year, and pay your user fees by October 1, or the next business day if it falls on a weekend or holiday. - How do you submit?
You’ll submit electronically in Health Level Seven Structured Product Labeling (SPL) format through the FDA’s system.
How Intertek Can Help
Intertek can assist you at every step , from determining whether you need to self-identify, to preparing and submitting your SPL files, and making sure your user fees are correctly calculated and paid on time. With our guidance, you’ll avoid compliance risks and keep your products on the market without disruption.
Don’t leave your compliance to chance, talk to Intertek to make your GDUFA self-identification and user fee process worry-free.
